Home Regulatory Affairs Sr Professionas II | Regulatory Affairs CMC | Novo Nordisk | Bangalore

Sr Professionas II | Regulatory Affairs CMC | Novo Nordisk | Bangalore

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Novo Nordisk is a global healthcare company with 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, hemophilia, growth disorders, and other serious chronic diseases.

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To work for Novo Nordisk you will need the skills, dedication, and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

At Novo Nordisk, your skills, dedication, and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Are you looking for the opportunity to make our patients’ lives better and leave your footprint! Then maybe you are the “Senior Regulatory Professional Chemistry, Manufacturing and Controls (CMC) Biopharm Established Products” we need for an exciting project.

Designation: Senior Professionals II – Regulatory Affairs CMC

Location: Bangalore, Karnataka, India

Job Description:

About the department

  • Global Regulatory Affairs (GRA) in Bangalore consists of eight departments that work across our global processes and support both colleagues in Head Quarter Denmark (DK) as well as colleagues in our affiliates all over the world.
  • As the area is growing, the total area will by midyear 2019 consist of approximately 120 dedicated employees.
  • Regulatory Operations, Global Business Services (GBS) is an integral part of Regulatory Operations DK.
  • The objective of this team is to ensure efficient and competitive Regulatory Operations to support Regulatory Affairs HQ and RA Affiliates.
  • The team provides services in Submission Management, Regulatory Information Management, and Operational Graphic Design.

The position

  • As a Senior RA professional main function is to plan, prepare, and submit high-quality files to the authorities achieving fast approvals for products within the department area of responsibility.
  • You will be responsible for planning, coordination and executing the regulatory tasks as required in the projects or existing products in accordance with the regulatory strategy for the defined area of responsibility
  • Furthermore, you will be responsible for the preparation and compilation of the individual sections of all files for the defined area of responsibility, in accordance with internal requirements and external regulatory guidelines and regulations.
  • This role requires providing regulatory interaction concerned with scientific issues with affiliates and authorities for all files within the defined area of responsibility and it includes evaluation of the regulatory implications of changes and necessary actions.
  • Additionally, you will be responsible CMC part of the Insulin portfolio, Defined standard CMC variation applications (e.g. Additional manufacturing site, an extension of product shelf life, new cell banks) and manufacturing site submissions, follow-up, and approvals.

Desired Candidate Profile:

  • Experience within global Regulatory Affairs CMC. Supplemented with experience from related areas in pharmaceutical industry e.g. production, product development or production QA.
  • Work experience with European medicines agencies, EMA, and with US FDA.
  • Require analytical mind set, innovative and customer-oriented skills with the ability to focus on detail without losing the overview
  • Focuses on targets and delivering results
  • Assesses and solves problems effectively
  • Ability to work in teams and to collaborate across functions
  • Communicates openly and effectively and negotiates with impact and influence

Qualification: M.Pharma

Experience: 6 to 8 years of relevant experience in Regulatory Affairs CMC

Salary: Negotiable

Contact Details:

Ms. Sudha: zras@novonordisk.com

Last Date: 30th Sep 2020

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